口服固体制剂溶出度测定方法的研究与应用进展

Abstract
Figure/Table
References (28)
Related Citation (0)

Download: PDF (537 KB) HTML (1 KB)
Export: BibTeX | EndNote (RIS)

Abstract [Abstract] Solid oral drugs must undergo dissolution in gastrointestinal fluid before they can be absorbed and reach the systemic circulation. Dissolution test is an in vitro method that simulates the disintegration and dissolution of solid oral drugs in the gastrointestinal tract, which plays a more and more important role in the prescription optimization and quality evaluation. A lot of studies on dissolution technology have been made to obtain higher levels of in vivo and in vitro correlation and ensure the consistency of the quality and efficacy of oral dosages. This paper summarized the research progress of dissolution medium and dissolution device and their applications in some particular dosages, it is hoped to provide some reference for other researchers committed to quality evaluation of oral solid preparation and development of generic drugs.

Key words： [Key words] Solid oral dosage Dissolution Dissolution medium Dissolution device

	Service

	E-mail this article
	Add to my bookshelf
	Add to citation manager
	E-mail Alert
	RSS
	Articles by authors
	ZHANG Wei1 LIU Jianfang2 ZHAO Caixia2

Cite this article:

ZHANG Wei1 LIU Jianfang2 ZHAO Caixia2. Advances in the research and application of dissolution method for oral solid dosage forms[J]. 中国医药导报, 2016, 13(3): 48-50，63.

URL:

http://www.yiyaodaobao.com.cn/EN/ OR http://www.yiyaodaobao.com.cn/EN/Y2016/V13/I3/48

[参考文献]
[1] 胡昌勤，潘瑞雪.溶出度试验评价/预测固体口服制剂生物等效性的研究进展[J].中国新药杂志，2014，23（1）：44-51.
[2] Garbacz G，Kolodziej B，Koziolek M，et al. An automated system for monitoring and regulating the pH of bicarbonate buffers [J]. AAPS Pharm Sci Tech，2013，14（2）：517-522.
[3] Garbacz G，Kolodziej B，Koziolek M，et al. A dynamic system for the simulation of fasting luminal pH-gradients using hydrogen carbonate buffers for dissolution testing of ionisable compounds [J]. Eur J Pharm Sci，2014，51（1）： 224-231.
[4] Varum FJ，Merchant HA，Goyanes A，et al. Accelerating the dissolution of enteric coatings in the upper small intestine： evolution of a novel pH 5.6 bicarbonate buffer system to assess drug release [J]. Int J Pharm，2014，468（1-2）：172-177.
[5] Desai D，Wong B，Huang Y，et al. Surfactant-mediated dissolution of metformin hydrochloride tablets：wetting effects versus ion pairs diffusivity [J]. J Pharm Sci，2014，103（3）：920-926.
[6] Smith AP，Moore TW，Westenberger BJ，et al. In vitro dissolution of oral modified-release tablets and capsules in ethanolic media [J]. Int J Pharm，2010，398（1-2）：93-96.
[7] 李帅，李文莉，王斌，等.尼莫地平口服固体制剂溶出度的研究[J].中南药学，2011，10（8）：567-571.
[8] 谢沐风，张启明，陈洁，等.国外药政部门采用溶出曲线评价口服固体制剂内在品质情况简介[J].中国药事，2008， 22（3）：257-261.
[9] 王丽葵，陈中亚，王威，等.国内外溶出度测定及评价方法的异同点[J].中国医药工业杂志，2015，46（5）：519-524.
[10] Mudie DM，Shi Y，Ping H，et al. Mechanistic analysis of solute transport in an in vitro physiological two-phase dissolution apparatus [J]. Biopharm Drug Dispos，2012，33（7）：378-402.
[11] 国家药典委员会.中国药典[S].二部.北京：中国医药科技出版社，2010：83-85.
[12] Galia E，Nicolaides E，Reppas C，et al. New media discriminate dissolution properties of poorly soluble drugs [J]. Pharm Res，1996，13（Supplement）：S262.
[13] Jantratid E，Janssen N，Reppas C，et al. Dissolution media simulating conditions in the proximal human gastrointestinal tract： an update [J]. Pharm Res，2008，25（7）：1663-1676.
[14] Kambayashi A，Blume H，Dressman JB. Predicting the oral pharmacokinetic profiles of multiple-unit （pellet） dosage forms using a modeling and simulation approach coupled with biorelevant dissolution testing：case example diclofenac sodium [J]. Eur J Pharm Biopharm，2014，87（2）：236-243.
[15] Arndt M，Chokshi H，Tang K，et al. Dissolution media simulating the proximal canine gastrointestinal tract in the fasted state [J]. Eur J Pharm Biopharm，2013，84（3）：633-641.
[16] 付莉娜，郑金琪，郑国钢，等.生物相关性溶出介质的研究进展[J].中国药学杂志，2013，48（24）：2084-2088.
[17] Klein S，Garbacz G，Pislar M，et al. The role of individual gastric emptying of pellets in the prediction of diclofenac in vivo dissolution [J]. J Control Release，2013，166（3）：286-293.
[18] Franek F，Holm P，Larsen F，et al. Interaction between fed gastric media（Ensure PlusR）and different hypromellose based caffeine controlled release tablets：comparison and mechanistic study of caffeine release in fed and fasted media versus water using the USP dissolution apparatus 3 [J]. Int J Pharm，2014，461（1-2）：419-426.
[19] Fotaki N，Vertzoni M. Biorelevant dissolution methods and their applications in in vitro in vivo correlations for oral formulations [J]. The Open Drug Delivery Journal，2010，4（1）：2-13.
[20] 赵洁，易红，刘晓谦，等. 流通池法测定药物溶出度的应用进展[J].中国药学杂志，2014，49（17）：1486-1490.
[21] 刘曦，王亚敏，潘阿慧，等.流通池法考察双氯芬酸钠缓释片的体外释放特性[J].中国药学杂志，2013，48（16）：1389-1393.
[22] Abrahamsson B，Pal A，Sj■berg M，et al. A novel in vitro and numerical analysis of shear-induced drug release from extended-release tablets in the fed stomach [J]. Pharm Res，2005，22（8）：1215-1226.
[23] Garbacz G，Golke B，Wedemeyer RS，et al. Comparison of dissolution profiles obtained from nifedipine extended release once a day products using different dissolution test apparatuses [J]. Eur J Pharm Sci，2009，38（2）：147-155.
[24] Cassilly D，Kantor S，Knight LC，et al. Gastric emptying of a non-digestible solid：assessment with simultaneous SmartPill pH and pressure capsule，antroduodenal manometry，gastric emptying scintigraphy [J]. Neurogastroenterol Motil，2008，20（4）：311-319.
[25] Garbacz G，Wedemeyer RS，Nagel S，et al. Irregular absorption profiles observed from diclofenac extended release tablets can be predicted using a dissolution test apparatus that mimics in vivo physical stresses [J]. Eur J Pharm Biopharm，2008，70（2）：421-428.
[26] Kobayashi M，Sada N，Sugawara M，et al. Development of a new system for prediction of drug absorption that takes into account drug dissolution and pH change in the gastro-intestinal tract [J]. Int J Pharm，2001，221（1-2）：87-94.
[27] Li ZQ，He X，Gao X，et al. Study on dissolution and absorption of four dosage forms of isosorbide mononitrate： level A in vitro-in vivo correlation [J]. Eur J Pharm Biopharm，2011，79（2）：364-371.
[28] Hou J，He X，Xu X，et al. Application of an in vitro DDASS to evaluate oral absorption of two chemicals simultaneously： establishment of a level A in vitro-in vivo correlation [J]. Drug Dev Ind Pharm，2012，38（11）：1305-1312.